Are you a Regulatory Affairs Specialist professional with experience supporting regulated products across global markets?
Were looking for a Regulatory Affairs Specialist to take ownership of product Technical Files and support regulatory activities across multiple international markets.
Salary & Benefits
£32,000 - £42,000 (dependent on experience)
1 day WFH per week
33 days holiday (inclusive of bank holidays) plus holiday trading scheme
Pension
Life assurance
Plus additional benefits
What youll be doing
Owning and maintaining product Technical Files across key global registration jurisdictions
Creating key regulatory documents including Risk Management files, GSPR, Device Descriptions, and labelling
Organising and supplying documentation for NPD and EU MDR submissions / global registrations
Supporting the resolution of regulatory-owned quality plans and economic operator agreements
Identifying applicable standards and external test requirements and proposing options to the Regulatory Manager
Leading on label creation and templates, resolving operational labelling queries, and contributing to multi-site labelling projects
Liaising cross-functionally to support Regulatory activities
Maintaining regulatory logs and supporting internal/external documentation requests
Monitoring regulatory and industry changes and assessing impact on registrations and processes
What were looking for
Essential:
Degree (or equivalent) in a scientific or engineering discipline
Minimum 1 years experience in Regulatory Affairs Specialist within Medical Devices
Strong working knowledge of EU MDR 2017/745, UK MDR 2002, ISO 13485 & ISO 14971
Excellent written and verbal communication skills
Ability to work independently and collaboratively in a multi-disciplinary environment
Proficiency with MS Word, Excel, PowerPoint, and Adobe tools
Desirable:
Participation in internal auditing programmes
Experience with MDSAP countries and/or FDA registrations
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